MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY S SYSTEM; TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN

Catalog Number	06P16-01
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a loud pop sound coming from the alinity s (sn: (b)(6)) followed by a burning smell and loss of power to the entire instrument.The circuit breaker for the analyzer tripped.The analyzer was unplugged and upon assessment the burning smell was coming from the power supply area.The 48 volt power supply board had burning / charring that extended across multiple components.A new power supply was installed, and the instrument is now powering on and reportedly passed initialization, daily maintenance and qc.There was no reported injury related to the event and no impact to patient management was reported.
Additional Manufacturer Narrative
The alinity s system serial number (sn) (b)(6) was evaluated.An evaluation of the power supply: 1500 w: 48vdc found no obvious signs of external damage, however it was noted that there was charring on an internal board.There were no signs of dried fluid from the instrument that would cause a short circuit failure.The evidence of charring of the power supply: 1500 w: 48vdc (part number b-10002356-01) was limited to the board on the inside of the unit and did not spread to other parts on the instrument.A review of the instrument service history identified no additional issues or contributing factors to the customer reported event.A search for similar complaints of the power supply: 1500 w: 48vdc did not yield any other complaints aside from the current customer reported event.A review of tracking and trending did not identify a trend for the power supply: 1500 w: 48vdc or the alinity s system with regards to the customer reported event.A review of the manufacturing documentation did not identify any issues for the power supply: 1500 w: 48vdc.Labeling was reviewed and was found to address the customer reported issue.Abbott equipment and accessories are certified to the safety standards, and adequate protection is provided for the operator against electric shock or burn and the spread of fire from the equipment.Based on the available information, no systemic issue or deficiency was identified.
Event or Problem Description
The customer reported a loud pop sound coming from the alinity s (sn: (b)(6)) followed by a burning smell and loss of power to the entire instrument.The circuit breaker for the analyzer tripped.The analyzer was unplugged and upon assessment the burning smell was coming from the power supply area.The 48 volt power supply board had burning / charring that extended across multiple components.A new power supply was installed, and the instrument is now powering on and reportedly passed initialization, daily maintenance and qc.There was no reported injury related to the event and no impact to patient management was reported.

• Brand Name: ALINITY S SYSTEM
• Common Device Name: TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 19756037
• Report Number: 1628664-2024-00005
• Device Sequence Number: 15097950
• Product Code: MZA
• UDI-Device Identifier: 00380740138479
• UDI-Public: (01)00380740138479
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 06P16-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown